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A Study to Compare the Steady-State Bioavailability of Injectable Letrozole SIE and Oral Letrozole in Post-Menopausal Women With Hormone Receptor Positive Early Breast Cancer
Sponsor: Rovi Pharmaceuticals Laboratories
Summary
The study aims to compare the amount of the drug letrozole that gets into the bloodstream after multiple doses of the quarterly injection Letrozole SIE, versus multiple doses of the standard oral daily tablet of letrozole (Femara®), in women who have gone through menopause and have received treatment for hormone receptor-positive early breast cancer. Participants must have completed at least five years of hormone therapy with at least two of those years with letrozole before starting their participation in the study. Women who have completed four years of hormone therapy are also eligible if their doctor considers them at low risk of cancer returning.
Official title: An Open-Label, One-Sequence Study to Evaluate the Steady-State Comparative Bioavailability of Quarterly Letrozole SIE and Once Daily 2.5 mg Oral Letrozole (Femara®) in Post-Menopausal Women Treated With Endocrine Therapy for Hormone Receptor-Positive Early Breast Cancer. (SIE-1)
Key Details
Gender
FEMALE
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-06-08
Completion Date
2028-10
Last Updated
2026-10-09
Healthy Volunteers
No
Interventions
US-sourced oral Femara® + Letrozole SIE
US-sourced Femara® 2.5 mg/day oral for 14 days (treatment period 1) + quarterly injectable Letrozole SIE (treatment period 2)
EU sourced oral Femara® + Letrozole SIE
EU-sourced oral Femara® 2.5 mg/day for 14 days (treatment period 1) + quarterly injectable Letrozole SIE (treatment period 2)
Locations (21)
Precision NextGen Oncology and Research Center (Investigational Site number USA-001)
Beverly Hills, California, United States
D&H National Research Centers INC (Investigational Site number USA-002)
Margate, Florida, United States
United Medical Research (Investigational Site number USA-005)
Port Orange, Florida, United States
Investigational Site number SRB-004
Belgrade, Serbia
Investigational Site number SRB-002
Belgrade, Serbia
Investigational Site number SRB-001
Kamenitz, Serbia
Investigational Site number SRB-003
Kragujevac, Serbia
Investigational Site number SRB-005
Niš, Serbia
Hospital Universitario Fundación Alcorcón (Investigational Site number ESP-015)
Alcorcón, Spain
NEXT Oncology. Phase I Unit / IOB - Hospital Quironsalud Barcelona (Investigational Site number ESP-002)
Barcelona, Spain
Hospital Universitario Virgen de las Nieves (Investigational Site number ESP-011)
Granada, Spain
Hospital Universitario de Jaén (HUJ) (Investigational Site number ESP-005)
Jaén, Spain
Complejo Asistencial Universitario de León - Hospital de León (Investigational Site number ESP-013)
León, Spain
Hospital Universitario Arnau de Vilanova de Lleida (Investigational Site number ESP-003)
Lleida, Spain
Althaia Xarxa Assistencial Universitària de Manresa F.P (Investigational Site number ESP-012)
Manresa, Spain
Hospital Quirónsalud Málaga (Investigational Site number ESP-001)
Málaga, Spain
Hospital Clínico Universitario Virgen de la Arrixaca (Investigational Site number ESP-009)
Murcia, Spain
NEXT Oncology Phase I Unit - Hospital Universitario Quironsalud Madrid (Investigational Site number ESP-008)
Pozuelo de Alarcón, Spain
Hospital Universitari Sant Joan de Reus (Investigational Site number ESP-004)
Reus, Spain
Consorci Corporació Sanitària Parc Taulí - Hospital de Sabadell (Investigational Site number ESP-006)
Sabadell, Spain
Hospital Clinico Universitario Santiago de Compostela (Investigational Site number ESP-007)
Santiago de Compostela, Spain